NCT00908362

Brief Summary

Airway dendritic cells (DCs) play a key role in smoke-related lung diseases. In this study, the researchers investigate the effects of fluticasone and salmeterol on human airway DCs in smokers. The researchers hypothesize that fluticasone and salmeterol impact on the number and the characteristics of airway DCs in smokers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 13, 2010

Status Verified

May 1, 2009

Enrollment Period

5 months

First QC Date

May 20, 2009

Last Update Submit

January 12, 2010

Conditions

Smoke-related Lung DiseasesChronic Obstructive Pulmonary Disease

Keywords

Dendritic cellsAirwaySmokerCOPD

Outcome Measures

Primary Outcomes (1)

  • The number and the CCR7 expression of DCs in bronchoalveolar lavage fluid before and after therapy with fluticasone or fluticasone/salmeterol, as compared to placebo.

    2 time points (A and B). Time point A: day 0 (directly before the inhalation therapy). Time point B: day 29 (directly after the inhalation therapy).

Secondary Outcomes (1)

  • The expression of other surface molecules on DCs in bronchoalveolar lavage fluid before and after therapy with fluticasone or fluticasone/salmeterol, as compared to placebo.

    2 time points (A and B). Time point A: day 0 (directly before the inhalation therapy). Time point B: day 29 (directly after the inhalation therapy).

Study Arms (3)

A

ACTIVE COMPARATOR

Inhalation of Fluticasone (via discus) twice daily for 28 days

Drug: fluticasone

B

ACTIVE COMPARATOR

Inhalation of Fluticasone and Salmeterol (via discus) twice daily for 28 days

Drug: fluticasone/salmeterol

C

PLACEBO COMPARATOR

Inhalation of Placebo (via discus) twice daily for 28 days.

Drug: placebo

Interventions

fluticasoneDRUG

Participants inhale fluticasone (250 µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.

A
fluticasone/salmeterolDRUG

Participants inhale fluticasone/salmeterol (250/50µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.

B
placeboDRUG

Participants inhale placebo twice daily via discus. Before and after this therapy, a bronchoalveolar lavage is performed.

C

Eligibility Criteria

Age30 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men aged 30 - 60 years
  • At least 15 years of smoking
  • Current smoker, at least 10 cigarettes per day

You may not qualify if:

  • Any acute or chronic disease (except COPD oder hypertension)
  • Any regular medication (except drugs against hypertension)
  • FEV1 \< 80% predicted
  • Oxygen saturation \< 90%
  • Acute infections of the lower respiratory tract in the last 7 days before the first day of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Pneumology, University of Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Related Publications (2)

  • Bratke K, Klug M, Bier A, Julius P, Kuepper M, Virchow JC, Lommatzsch M. Function-associated surface molecules on airway dendritic cells in cigarette smokers. Am J Respir Cell Mol Biol. 2008 Jun;38(6):655-60. doi: 10.1165/rcmb.2007-0400OC. Epub 2008 Jan 18.

    PMID: 18203971BACKGROUND

  • Lommatzsch M, Kraeft U, Troebs L, Garbe K, Bier A, Stoll P, Klammt S, Kuepper M, Bratke K, Virchow JC. Fluticasone impact on airway dendritic cells in smokers: a randomized controlled trial. Respir Res. 2013 Oct 29;14(1):114. doi: 10.1186/1465-9921-14-114.

    PMID: 24168756DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

FluticasoneFluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSalmeterol XinafoateAlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 25, 2009

Study Start

May 1, 2009

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

January 13, 2010

Record last verified: 2009-05

Locations

DE(1)